Cervical Spinal Cord InjuryPhase 2NCT02163876
Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury
A Phase 2 study testing HuCNS-SC cells in people with Cervical Spinal Cord Injury and Spine Injury, run by StemCells, Inc. at 14 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Spinal Cord Injury, Spine Injury, Cervical Spine Injury
- What is being tested?
- HuCNS-SC cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Oct 2014to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects age 18 to 60 years.
- Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) as determined by the Investigator.
- American Spinal Injury Association Impairment Scale (AIS) Grades B or C
- Minimum of 12 weeks post-injury prior to Screening
Who cannot join
- History of penetrating SCI.
- MRI evidence of complete spinal cord interruption .
- Evidence of spinal instability, stenosis and/or persistent cord compression related to the initial trauma.
- Prior participation in another investigational study within 90 days prior to Screening.
- Previous organ, tissue, bone marrow transplantation, or gene transfer
- History of malignancy (except non-melanoma skin cancers) that require(d) radiation and/or chemotherapy
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Maryland Medical Systems
Baltimore, Maryland, 21201
Northwestern University
Chicago, Illinois, 60611
Rancho Los Amigos National Rehabilitation Center/USC
Downey, California, 90242
University of Texas, Mischer Neuroscience Institute
Houston, Texas, 77030
University of Miami Miller School of Medicine
Miami, Florida, 33136
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226
University of Minnesota/Courage Kenny Rehabilitation Institute
Minneapolis, Minnesota, 55414
Mount Sinai Medical Center, Dept of Neurosurgery
New York, New York, 10029
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
Canada2 sites
Foothills Medical Center
Calgary, Alberta, T2N 2T9
Toronto Western Hospital
Toronto, Ontario, M9R1L5
About this study
Official title: A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Transplantation in Cervical Spinal Cord Injury
This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.
- Being tested
- HuCNS-SC cells
- Keywords
- spine, injury, trauma, spine injury, cervical spine injury, cervical spine, stemcells transplantation
- Medical subject headings
- Spinal Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuCNS-SC cellsDrug
Also called human neural stem cells, HuCNS-SC, HCNS-SC
surgery arm
| Study group | Role | What they receive |
|---|---|---|
| HuCNS-SC cells | Experimental | Intramedullary transplantation of HuCNS-SC cells in the cervical spine Receives: Drug: HuCNS-SC cells |
| non-surgery arm | No intervention | non-surgery arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in ISNCSCI upper extremity motor scores
Measured: Up to one year after enrollment
Secondary outcomes (1)
Number of participants with serious and non-serious adverse events
Safety measures will include collection of adverse events, laboratory tests, neurological examination, ISNCSCI motor and sensory scores, pain and allodynia assessment, AIS grade, physical examination and modified Ashworth scale
Measured: Up to one year from the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Based on a business decision unrelated to any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- StemCells, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Huhn, MD, Study director, StemCells, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163876
- Sponsor's protocol ID
- CL-SCI-201
- Status last verified
- May 2016
- First submitted
- 12 Jun 2014
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahuja CS, Fehlings M. Concise Review: Bridging the Gap: Novel Neuroregenerative and Neuroprotective Strategies in Spinal Cord Injury. Stem Cells Transl Med. 2016 Jul;5(7):914-24. doi: 10.5966/sctm.2015-0381. Epub 2016 Apr 29.
PubMed 27130222
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Transplantation in Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02163876
- Acronym / sponsor ID
- CL-SCI-201
- Keywords
- spine, injury, trauma, spine injury, cervical spine injury, cervical spine, stemcells transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on a business decision unrelated to any safety concerns.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- StemCells, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HuCNS-SC cells | Experimental | Drug: HuCNS-SC cellsIntramedullary transplantation of HuCNS-SC cells in the cervical spine |
| non-surgery arm | No intervention | –non-surgery arm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female subjects age 18 to 60 years.
- Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) as determined by the Investigator.
- American Spinal Injury Association Impairment Scale (AIS) Grades B or C
- Minimum of 12 weeks post-injury prior to Screening
Key exclusion criteria (6 listed)
- History of penetrating SCI.
- MRI evidence of complete spinal cord interruption .
- Evidence of spinal instability, stenosis and/or persistent cord compression related to the initial trauma.
- Prior participation in another investigational study within 90 days prior to Screening.
- Previous organ, tissue, bone marrow transplantation, or gene transfer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HuCNS-SC cellsAlso: human neural stem cells, HuCNS-SC, HCNS-SCsurgery arm | Drug | HuCNS-SC cells |
Primary outcome
Change from baseline in ISNCSCI upper extremity motor scores
Time frame: Up to one year after enrollment
1 secondary outcome
Number of participants with serious and non-serious adverse events
Time frame: Up to one year from the time of enrollment
Results and safety
The study was stopped early (reason given: Based on a business decision unrelated to any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Derived from this study: PubMed 27130222Ahuja CS, Fehlings M. Concise Review: Bridging the Gap: Novel Neuroregenerative and Neuroprotective Strategies in Spinal Cord Injury. Stem Cells Transl Med. 2016 Jul;5(7):914-24. doi: 10.5966/sctm.2015-0381. Epub 2016 Apr 29.
- Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Huhn, MD study director
StemCells, Inc.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HuCNS-SC cells in people with Cervical Spinal Cord Injury and Spine Injury, run by StemCells, Inc. at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on a business decision unrelated to any safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in ISNCSCI upper extremity motor scores (time frame: Up to one year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016.